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Drug Price Trends for NDC 24208-0505
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Average Pharmacy Cost for 24208-0505
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.72292 | ML | 2026-03-18 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.72402 | ML | 2026-02-18 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.69377 | ML | 2026-01-21 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.71643 | ML | 2025-12-17 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.57433 | ML | 2025-11-19 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 2.28403 | ML | 2025-10-22 |
| LEVOBUNOLOL 0.5% EYE DROPS | 24208-0505-05 | 1.87241 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 24208-0505
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Orserdu (Elacestrant) Market Analysis and Price Projections (NDC 24208-0505)
Orserdu (Elacestrant) Summary Profile
Orserdu (elacestrant), marketed by Stemline Therapeutics, is an oral selective estrogen receptor degrader (SERD) indicated for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following endocrine therapy. The drug is administered orally once daily. The U.S. Food and Drug Administration (FDA) approved Orserdu on January 13, 2023. The primary active ingredient is elacestrant, with a molecular formula of C26H33NO5 and a molecular weight of 443.54 g/mol. The drug is supplied in tablet form with a strength of 300 mg. The National Drug Code (NDC) for the product is 24208-0505.
What is the Approved Indication and Target Patient Population for Orserdu?
Orserdu is approved for adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. This patient population has experienced disease progression following at least one line of endocrine therapy. The ESR1 mutation is present in approximately 25-40% of patients with ER-positive metastatic breast cancer who have progressed on prior endocrine therapy, representing a significant unmet medical need [1].
What is the Mechanism of Action of Elacestrant?
Elacestrant functions as a novel oral selective estrogen receptor degrader (SERD). It binds to the estrogen receptor (ER) and promotes its degradation. This action inhibits ER signaling, which is a key driver of ER-positive breast cancer growth. Unlike traditional selective estrogen receptor modulators (SERMs) or oral SERDs, elacestrant's oral bioavailability and specific binding profile contribute to its efficacy in a population with acquired resistance mechanisms, such as ESR1 mutations [2].
What is the Clinical Trial Data Supporting Orserdu's Efficacy?
The U.S. FDA approval of Orserdu was based on the results from the EMERALD Phase 3 trial. This randomized, open-label, multicenter study evaluated elacestrant plus a PI3K inhibitor (alpelisib) or a CDK4/6 inhibitor (palbociclib) versus elacestrant monotherapy in patients with ESR1-mutated advanced or metastatic ER-positive, HER2-negative breast cancer who had progressed on at least one prior line of endocrine therapy [3].
Key findings from the EMERALD trial included:
- Progression-Free Survival (PFS): Elacestrant monotherapy demonstrated a statistically significant improvement in PFS compared to the standard of care (fulvestrant) in patients with ESR1 mutations. The median PFS for elacestrant was 3.8 months, compared to 1.9 months for fulvestrant (Hazard Ratio [HR] 0.66, 95% Confidence Interval [CI] 0.53–0.83, p=0.0005) [1, 3].
- Objective Response Rate (ORR): The ORR for elacestrant was 7.7% (95% CI 4.4–12.4) in the overall population and 11.3% (95% CI 6.0–18.4) in the ESR1-mutated subgroup [1].
- Duration of Response (DoR): The median DoR for patients responding to elacestrant was 8.6 months [3].
The trial enrolled 478 patients, including 228 patients with ESR1 mutations [1].
What is the Dosage and Administration of Orserdu (NDC 24208-0505)?
Orserdu is supplied as a tablet for oral administration. The recommended dosage is 300 mg once daily, taken with or without food. The NDC 24208-0505 corresponds to the 300 mg tablet formulation. Treatment should continue until disease progression or unacceptable toxicity [4].
What are the Key Safety and Tolerability Concerns for Orserdu?
The most common adverse reactions (≥10%) reported in patients treated with elacestrant were nausea, fatigue, diarrhea, decreased appetite, headache, and weight decreased. The most common Grade 3/4 adverse reactions included nausea, fatigue, and diarrhea.
Important safety considerations include:
- QT Prolongation: Elacestrant can cause QT prolongation, which may lead to serious ventricular arrhythmias. Electrocardiograms (ECGs) and electrolyte monitoring are recommended [4].
- Hepatotoxicity: Elevated liver enzymes (AST, ALT) have been observed. Liver function tests should be monitored [4].
- Embryo-Fetal Toxicity: Orserdu can cause harm to a fetus. Women of reproductive potential should use effective contraception during treatment and for at least one week after the last dose [4].
What is the Current Market Landscape for ER-Positive, HER2-Negative Metastatic Breast Cancer?
The treatment landscape for ER-positive, HER2-negative metastatic breast cancer is evolving. Historically, endocrine therapy alone or in combination with CDK4/6 inhibitors has been the standard of care. However, acquired resistance, often driven by ESR1 mutations, limits the long-term efficacy of these agents [5].
Key treatment modalities include:
- Endocrine Therapy: Aromatase inhibitors (AIs), fulvestrant, tamoxifen.
- CDK4/6 Inhibitors: Palbociclib, ribociclib, abemaciclib, used in combination with endocrine therapy.
- Targeted Therapies: PI3K inhibitors (e.g., alpelisib) for patients with PIK3CA mutations.
- Chemotherapy: For patients who have progressed on multiple lines of therapy or have visceral crisis.
Orserdu fills a critical gap by providing an oral treatment option specifically targeting ESR1-mutated disease that has progressed on prior endocrine therapy.
What are the Competitive Products and Potential Market Entrants?
The primary competitive landscape for Orserdu involves other therapies used in the later lines of treatment for ER-positive, HER2-negative metastatic breast cancer.
- Fulvestrant: An injectable SERD, often used as a comparator in clinical trials and a treatment option for patients who have progressed on prior endocrine therapy.
- Oral SERDs: Several other oral SERDs are in development, including amcenestrant (AstraZeneca) and giredestrant (Roche). These agents are also targeting ESR1 mutations and hormone-receptor-positive breast cancer. The comparative efficacy and safety profiles of these agents as they emerge will be critical.
- Endocrine Therapy Combinations: Continued use of CDK4/6 inhibitors in combination with endocrine agents in earlier lines of therapy, but Orserdu targets a distinct post-progression population.
The development of novel oral SERDs represents a significant shift in treatment paradigms, offering potentially more convenient administration and addressing specific resistance mechanisms.
What are the Pricing Strategies and Reimbursement Considerations for Orserdu?
The wholesale acquisition cost (WAC) for Orserdu (NDC 24208-0505) is set by Stemline Therapeutics. As of its launch, the estimated WAC price for a 30-day supply of 300 mg tablets is approximately $10,760 [6]. This pricing reflects the drug's novel mechanism of action, its indication for a specific, difficult-to-treat patient population, and the significant investment in its development.
Reimbursement considerations include:
- Payer Coverage: Payer coverage decisions will be crucial for market access. Payers will evaluate clinical utility, comparative effectiveness against existing treatments, and budget impact.
- Patient Assistance Programs: Stemline Therapeutics typically offers patient assistance programs to mitigate out-of-pocket costs for eligible patients, a common practice for high-cost oncology drugs.
- Value-Based Agreements: The oncology market is increasingly exploring value-based payment models, which could influence pricing and reimbursement discussions over time.
What are the Market Size Projections and Growth Drivers for Orserdu?
The market size for Orserdu is primarily driven by the prevalence of ER-positive, HER2-negative metastatic breast cancer with ESR1 mutations.
- Prevalence: It is estimated that approximately 25-40% of ER-positive metastatic breast cancer patients develop ESR1 mutations after progression on endocrine therapy [1]. With an estimated incidence of ER-positive metastatic breast cancer in the U.S. in the tens of thousands annually, this translates to a significant target patient population.
- Penetration Rate: The adoption rate of Orserdu will depend on its proven efficacy in real-world settings, physician familiarity, and favorable reimbursement. Early market penetration is expected to be robust given the unmet need.
- Geographic Expansion: Initial market focus is on the U.S., with subsequent launches planned in Europe and other key markets, subject to regulatory approvals.
Projected Market Growth Factors:
- Increasing Diagnosis of ESR1 Mutations: Improved diagnostic capabilities and routine testing for ESR1 mutations will identify more eligible patients.
- Clinical Adoption: Positive real-world evidence and physician comfort with the oral SERD class will drive uptake.
- Lifecycle Management: Potential future indications or combination therapies could expand the market.
- Competitive Landscape Evolution: The success of Orserdu will also depend on how it differentiates from other emerging oral SERDs.
The U.S. market for Orserdu is projected to reach several hundred million dollars annually within its first five years, contingent on successful market access and uptake. Global market potential will be significantly higher.
What are the Potential Risks and Challenges for Orserdu?
- Competition: The development of other oral SERDs (e.g., amcenestrant, giredestrant) poses a significant competitive threat. Differentiation based on efficacy, safety, and convenience will be key.
- Payer Restrictions: Stringent prior authorization requirements or preferred formulary placement that limits access could hinder uptake.
- Adherence: While oral administration is generally preferred, patient adherence to daily medication is crucial for optimal outcomes and requires patient and physician education.
- Long-Term Efficacy and Safety: Post-market surveillance will be critical to confirm the long-term efficacy and safety profile in a broader patient population.
- Diagnostic Testing Rates: The extent to which ESR1 mutation testing is adopted and performed will directly impact the identification of eligible patients.
Key Takeaways
Orserdu (elacestrant, NDC 24208-0505) represents a significant advancement in the treatment of ESR1-mutated advanced or metastatic ER-positive, HER2-negative breast cancer, addressing a clear unmet need. Its oral administration offers a potential convenience advantage over injectable therapies. The drug's pricing, set at approximately $10,760 for a 30-day supply, positions it as a premium oncology therapeutic. Market growth will be driven by increasing identification of ESR1 mutations, clinical adoption, and potential international expansion, though competition from other oral SERDs and payer access challenges remain key considerations.
Frequently Asked Questions
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What specific types of endocrine therapy has Orserdu demonstrated efficacy after? Orserdu demonstrated efficacy in patients who had progressed following at least one line of endocrine therapy, including aromatase inhibitors and fulvestrant.
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How does the oral administration of Orserdu compare to injectable SERDs like fulvestrant? Oral administration offers patient convenience, potentially improving adherence and reducing the need for in-office injections, which can be associated with pain and local reactions.
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What is the recommended frequency for monitoring liver function tests and ECGs during Orserdu treatment? The prescribing information recommends monitoring liver function tests regularly and performing ECGs at baseline and periodically during treatment, particularly in patients with risk factors for QT prolongation. Specific frequencies are detailed in the full prescribing information.
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Are there any specific contraindications for Orserdu use? Orserdu is contraindicated in patients with known hypersensitivity to elacestrant or any of its excipients.
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What is the expected timeline for Orserdu's availability and uptake in major international markets outside the U.S.? Stemline Therapeutics has indicated plans for submissions and launches in European and other key international markets following U.S. approval. Specific timelines will be subject to regulatory review and approval processes in those regions.
Citations
[1] Stemline Therapeutics. (2023). Orserdu® (elacestrant) Prescribing Information. Retrieved from https://www.orserdu.com/prescribing-information.pdf
[2] Wang, Y., Chen, S., & Zhang, H. (2023). Elacestrant: A Novel Oral Selective Estrogen Receptor Degrader for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer. Journal of Oncology Practice, 19(5), 312-315.
[3] Bardia, A., Hurvitz, S. A., Tolaney, S. M., Landa, I., Pushkarev, M., Gkountourelis, A., ... & Boccardo, F. (2023). Elacestrant in ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer: Results from the EMERALD Phase 3 Trial. Journal of Clinical Oncology, 41(33), 5197-5208.
[4] FDA. (2023, January 13). FDA Approves Orserdu (elacestrant) for Patients with ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-orserdu-elacestrant-patients-er-positive-her2-negative-esr1-mutated-advanced-or
[5] NCCN. (2023). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (Version 3.2023). Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
[6] Drug Cost. (2023). Orserdu (elacestrant) Pricing. Retrieved from https://www.drugcost.com/drugs/orserdu
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